MAUDE Adverse Event Report: ABBOTT BINAXNOW COVID-19 ANTIGEN SELF TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number 195-160

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2021

Event Type  malfunction  

Event Description

Purchased binaxnow covid-19 antigen test kit (2 test per pack).One of the test cards appears to be manufactured incorrectly.The test strip was installed and glued into place off center.The test strip was unable to update the liquid sample from the swab after 15 minutes.The test failed and did not register any results.I have enclosed pictures of the problem card.The packaging contains several different lot numbers.I'm not sure which is relevant so i also have included photos of the packaging.I still have the box, packaging, and sales receipt, but have discarded the card.Manufacture date: september 20, 2021 expiration date: march 20, 2022.Fda safety report id# (b)(4).

• Brand Name: BINAXNOW COVID-19 ANTIGEN SELF TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ABBOTT
• MDR Report Key: 13110569
• MDR Text Key: 282972095
• Report Number: MW5106305
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00811877011408
• UDI-Public: (01)00811877011408
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 195-160
• Device Lot Number: 155772
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: BIOTIN ; CRANBERRY SUPPLEMENT; VITAMIN D
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White